Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 940-683-0 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Literature reference. No information on GLP. Level of information and not enough information to assess the study following an official and validated method, but the study is well conducted and scientifically valid
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- not specified
- Principles of method if other than guideline:
- NA
- GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Analytical grade, obtained from Serva (heidelberg)
- IUPAC Name:
- Analytical grade, obtained from Serva (heidelberg)
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 6 male + 6 female
12 -18 weeks old
weighing 30-40 g
Animal were in-house bred and had free access to laboratory chow and tap water
Animals were kept in temperature controlled rooms (21+/- 1°C) on a 12h light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Liquid paraffin
- Duration of treatment / exposure:
- Single treatment
- Frequency of treatment:
- Single
- Post exposure period:
- 24 h
30 h
48 h
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
10
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
100
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
500
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
5000
Basis:
nominal conc.
- No. of animals per sex per dose:
- 6 animals per sex per dose
- Control animals:
- yes
- Positive control(s):
- Busulfan
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Methyl ester of fatty acids in chain lenght from C6 to C20 (i.e. the read-across substance - see attached waiving and justification document in section 13) doesn't show chromosomal aberration on Chinese Hamster bone-marrow cells until a concentration of 5000 mg/Kg. This conclusion also apply for Fatty acids, C18 (saturated and unsaturated) ethyl esters. - Executive summary:
The clastogenic activity of methyl esters of fatty acids (short-chain to long-chain) were examined in Chinese hamster bone marrow cells using the chromosome aberration test (OECD 475). Experimental animals were treated with fatty acid esters and the mutagen (busulfan), to evaluate the anticlastogenic activity of the methyl esters of fatty acids on chromosome-breaking actions of busulfan.
In conclusion, methyl ester of fatty acids in chain length from C6 to C20 (i.e. the read-across substance - see attached waiving and justification document in section 13) doesn't show chromosomal aberration (clastogenic activity) on Chinese Hamster bone-marrow cells up to 5000 mg/kg. This conclusion also apply for Fatty acids, C18 (saturated and unsaturated) ethyl esters.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.